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In this study, the weight of the contents in the cartridge was tracked. A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The produt accountability product accountability information was not provided for the nicotine replaement patches replacement patches.    

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TEDP07DA10001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.3g2525g12004-06-06
2TEDP07DA10001

2

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001

3

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.1g2525g12020-06-07
4TEDP07DA10001

4

CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1414g22020-06-08
5TEDP07DA10001

5

CRT9955DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-08

EC was used to represent the collected exposure data since a double dummy -blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The sponsor represented each cartridge and patch used. The dose was represented as "1" to indicate one cartidge cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was reccorded on other days.           

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 Subject 10001 was randomized to the 5%  pharmaceutical strength of the nicotine e- nicotine liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The sponsor only represented the active product exposure for each subject in EX. Note, only repreesentive rows are included. 

Dataset wrap
Nameex
Dataset2

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

EXSTDTC

EXENDTC

1TEDP07EX10001 1e nicotine liquid 1.7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T08:002020-06-01T:8:10
2TEDP07EX10001 2e nicotine liquid 15.1gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T12:102020-06-02
3TEDP07EX10001 3e nicotine liquid 13gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-022020-06-03
4TEDP07EX100014e nicotine liquid 12gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-032020-06-04
5TEDP07EX10001 5e nicotine liquid 9gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-042020-06-05
6TEDP07EX100016e nicotine liquid 7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-10T08:302020-06-10T08:40
7TEDP07EX100017e nicotine liquid 5gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-10T12:402020-06-11
8TEDP07EX20001 1

nicotine replacement therapy

1PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE14mg2020-06-012020-06-02
9TEDP07EX200012nicotine replacement therapy1PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE14mg2020-06-022020-06-03
10TEDP07EX200013nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE14mg2020-06-032020-06-04
11TEDP07EX20001 4nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH PATCHTRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE14mg2020-06-102020-06-11